Status:
RECRUITING
A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)
Lead Sponsor:
Almirall, S.A.
Conditions:
Genital Psoriasis
Eligibility:
All Genders
18-99 years
Brief Summary
The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of psoriasis, with significant involvement of genital regions, i.e., sPGA-G greater than or equal to (\>=) 3.
- Need for systemic biologic therapy based on the local country specific regulations. Tildrakizumab, in accordance with the SmPC, must be the anti-IL23p19 selected therapy before including the patient in the study.
- Age 18 - 99 years.
- Informed consent in writing in accordance with applicable country regulations
- Patient must have plaque psoriasis affecting a body surface area (BSA) \>= 1% in a non-genital area at baseline.
- Patient willing and able to fill out study questionnaires.
Exclusion
- Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the investigator, should not participate in the study.
- Patient exposed to any experimental treatment in the past 3 months prior to baseline.
- Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
- Patient dependent on the investigator, including but not restricted to employees of the study site.
- Previous treatment with Tildrakizumab.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06029257
Start Date
November 14 2023
End Date
March 1 2026
Last Update
January 29 2025
Active Locations (1)
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1
Medizinische Universität Graz
Graz, Styria, Austria, 8020